Micronutrient Supplement for Nurse Burnout

NCT05363410 | Unknown

• 1 other identifier: 22-04-180
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to confirm and quantify the ability of an 8-week intervention with a supplement containing magnesium citrate and vitamin B6 to reduce anxiety, stress, and burnout among nurses working full time in hospitals and urgent care centers during the COVID-19 Pandemic.

Conditions

Burnout, Professional; Stress, Psychological

Outcome Measures

Primary Outcomes (1)

• Scores on the Depression Anxiety Stress Scale (DASS-42), stress sub-score after 8 weeks of intervention as compared to a control group, after controlling for baseline scores.

  The Depression Anxiety Stress Scale (DASS) 42 is a validated self report measure assessing depression, stress, and anxiety. The scale includes 42 total questions with 14 in each subscale. Higher scores indicate higher severity.

  8 weeks

Secondary Outcomes (3)

• Scores on the State-Trait Anxiety Inventory after 8 weeks of intervention as compared to a control group, after controlling for baseline scores.

  8 weeks

• Scores on the Maslach Burnout Inventory for Health Personnel after 8 weeks of intervention as compared to a control group, after controlling for baseline scores.

  8 weeks

• Number of participants with adverse events.

  8 weeks

Other Outcomes (4)

• Scores on the DASS-42 total, anxiety, and depression sub-scores after 8 weeks of intervention as compared to a control group, after controlling for baseline scores.

  8 weeks

• Scores on the Magnesium Deficiency Questionnaire (MDQ-62) after 8 weeks of intervention as compared to a control group, after controlling for baseline scores.

  8 weeks

• Scores on the DASS-42, MBI-HSS, and STAI after 4 weeks of intervention as compared to a control group, after controlling for baseline scores.

  4 weeks

Study Arms (2)

MagnéVie B6®

EXPERIMENTAL

Each film coated tablet contains 100mg magnesium citrate and 10mg pyridoxine hydrochloride.

Dietary Supplement: MagnéVie B6®

Placebo

PLACEBO COMPARATOR

Each identical film coated tablet contains inert materials.

Other: Placebo

Interventions

MagnéVie B6® DIETARY_SUPPLEMENT

micronutrient supplement

MagnéVie B6®

Placebo OTHER

placebo supplement

Placebo

Eligibility Criteria

• Age: 20 Years - 59 Years
• Gender Eligibility Details: self representation of gender identity
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Woman aged 20-59
• Lives in the United States
• In good general health as evidenced by medical history
• Stress subscale score from the DASS \> =22
• Ability to take oral medication and be willing to commit to taking 3 tablets a day for 8 weeks.
• For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional month after the end of MagnéVie B6® administration
• Employed full time as a nurse in a hospital, primary, or urgent care center that treats COVID-19 patients. Full time is defined as 35 hours or more each week.
• Agreement to adhere to Lifestyle Considerations throughout study duration

You may not qualify if:

• Current use of the following pharmaceuticals: bisphosphonates, calcium channel blockers, digoxin, aminoglycoside antibiotics, ketamine, levodopa/carbidopa, gabapentin, potassium sparing diuretics, quinolone antibiotics, skeletal muscle relaxants, sulfonylureas, tetracycline antibiotics, amiodarone, antihypertensives, or antiepileptic drugs (including phenytoin, valproic acid, carbamazepine, phenobarbital).
• Pregnancy, trying to conceive or breastfeeding
• Known allergic reactions to any components of the supplement including magnesium citrate anhydrous, pyridoxine hydrochloride, lactose anhydrous, magnesium stearate, hypromellose, macrogol 6000 titanium dioxide, or talc
• Positive COVID-19 test within 60 days of the study period
• COVID vaccine of any type scheduled during the intervention period or the week prior to the start of the study
• Current diagnosis or lifetime history of a bleeding disorder, kidney disease, or neuromuscular disease
• Recent dramatic weight changes (10% change in body weight in the last 6 months)
• Existing usage of a magnesium or vitamin B6 supplement

Sponsors & Collaborators

• Nutraceuticals Research Institute: lead
• Opella Healthcare Group SAS, a Sanofi Company: collaborator

Study Sites (1)

Franklin Health Research Center

Franklin, Tennessee, 37067, United States

Location

MeSH Terms

Conditions

Burnout, Professional; Stress, Psychological

Condition Hierarchy (Ancestors)

Occupational Stress; Occupational Diseases; Burnout, Psychological; Behavioral Symptoms; Behavior

Study Officials

• JESSIE HAWKINS, PhD

  Nutraceuticals Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

JESSIE HAWKINS, PhD

CONTACT

6152613116; info@franklinhealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2022
• First Posted: May 5, 2022
• Study Start: May 1, 2022
• Primary Completion: September 30, 2022
• Study Completion: April 30, 2023
• Last Updated: May 5, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)